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Fecal Microbiota Transplantation for Constipation

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ClinicalTrials.gov Identifier: NCT03308461
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Brief Summary:
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.

Condition or disease Intervention/treatment Phase
Gut Microbiota Constipation Drug: Fecal Microbiota suspension Not Applicable

Detailed Description:
Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for Constipation With Difficult Defecation
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fecal microbiota transplantation (FMT)
Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT.
Drug: Fecal Microbiota suspension
The prepared microbiota suspension was infused into mid-gut.




Primary Outcome Measures :
  1. defecation frequency [ Time Frame: 12 weeks ]
    frequency of defecation per week

  2. stool consistency [ Time Frame: 12 weeks ]
    The category of stool consistency score based on the BSS (Bristol Stool Form Scale)



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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 14-80 years old;
  2. difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation).

Exclusion Criteria:

  1. difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
  2. with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
  3. pregnant or breast-feeding women;
  4. infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308461


Locations
China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University

Publications:
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03308461     History of Changes
Other Study ID Numbers: FMT-CN-160107
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
difficult defecation
fecal microbiota transplantation
stool pattern

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms